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Trial record 41 of 195 for:    Hemorrhage AND SAH

The Mortality and Changes in Quality of Life of Patients Suffering From SAH With Different Hydration Strategies

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ClinicalTrials.gov Identifier: NCT02064075
Recruitment Status : Completed
First Posted : February 17, 2014
Last Update Posted : February 17, 2014
Sponsor:
Information provided by (Responsible Party):
Tamas Vegh, MD, University of Debrecen

Brief Summary:

Purpose:

- Vasospasm and secondary ischemia following subarachnoidal hemorrhage considerably affect the clinical outcome. The purpose of this study is to determine whether crystalloid (Lactated Ringer's solution) or colloid (hydroxyethyl starch) intravenous infusion is more effective in the treatment of subarachnoid hemorrhage (SAH)

Treatment:

- Patients are randomly divided into two groups. Depending on the blood pressure of the patients the members of the first group receive 15-50 ml/kg Lactated-Ringer's solution daily as part of the treatment, while the others 15 ml/kg Lactated-Ringer's and 15-50 ml/kg hydroxyethyl starch solution daily.

Measurements:

  • Neurological status of patients will be determined by the NIH Stoke Scale Score and the Glasgow Coma Scale (GCS) on a daily basis.
  • The mid-term survival and quality of life are evaluated with Barthel Index and Glasgow Outcome Scale (GOS) 14 and 30 days following admission to our clinic.

Hypothesis:

-The prevalence of vasospasms, the mortality rate and the medium-term quality of life following subarachnoid hemorrhage is improved if patients are treated with intravenous colloid (hydroxyethyl starch) infusion compared to intravenous crystalloid infusion.


Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage Drug: Lactated Ringer's solution Drug: Hydroxyethyl starch Phase 4

Detailed Description:

Study protocol:

  • Upon arrival Computed Tomography Angiography (CTA), or if necessary, a four-vessel cerebral angiography is carried out in case of each patient. Previous medical history is obtained with particular regard to the onset of the symptoms and the premorbid blood pressure values. Afterwards the Hunt-Hess classification of the patients take place. The neurological condition is recorded with the help of the NIH Stroke Scale on a daily basis. An acute or delayed open surgery or endovascular coiling is carried out by either a neurosurgeon or an interventional neuroradiologist as the definitive treatment of the aneurysm.
  • Patients are randomized into two groups, either treated with Lactated Ringer's or hydroxyethyl starch solutions. Patients of the Lactated Ringer's are given 15-50 ml/kg/day Lactated Ringer's infusion from the beginning of their enrollment, while members of the other group receive 15 ml/kg Lactated-Ringer's and 15-50 ml/kg hydroxyethyl starch solution daily. The blood pressure should not exceed the 160 mmHg systolic and 110 mm Hg mean value prior to the definitive treatment. After definitive care the target blood pressure is set to ensure a clinically optimal state, which should not above 150% of the premorbid blood pressure, and should not exceed 200/120 mmHg. In order to achieve and maintain these values additional vasoactive drugs (arterenol, dobutrex) could be administered regardless of the group in a maximum dose of 2.5 micrograms/kg/min arterenol, with an additional dose of 10 ug/kg/min dobutrex if necessary, if the sole intake of intravenous solutions are not sufficient. Blood pressure is measured invasively, continuously after the cannulation of the radial artery.
  • Neurological status of patients will be determined by the NIH Stoke Scale Score and the Glasgow Coma Scale (GCS) on a daily basis. The mid-term survival and quality of life are evaluated with Barthel Index and Glasgow Outcome Scale (GOS) 14 and 30 days following admission to our clinic.
  • The primary outcome measure of the study is the incidence rate of vasospasm in both groups, while secondary outcome measures included 30-day survival, the neurological status and GOS scores after.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Phase 4 Prospective, Randomized, Blinded Study on the Effect of Different Hydration Strategies on Mortality and Changes in Quality of Life of Patients Suffering From Subarachnoid Haemorrhage
Study Start Date : February 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Active Comparator: Hydroxyethyl starch
15 ml/kg Lactated-Ringer's and 15-50 ml/kg hydroxyethyl starch solution was given intravenously every day.
Drug: Hydroxyethyl starch
15 ml/kg Lactated-Ringer's and 15-50 ml/kg hydroxyethyl starch solution was given intravenously every day until discharge.
Other Name: HES 130/0.4

Active Comparator: Lactated Ringer's solution
15-50 ml/kg Lactated-Ringer's solution was given intravenously every day.
Drug: Lactated Ringer's solution
15-50 ml/kg Lactated-Ringer's solution was given intravenously every day until discharge.




Primary Outcome Measures :
  1. The incidence of vasospasm [ Time Frame: The presence of vasospasm is assessed daily between Day 1 and Day 14 in average (plus or minus 5 days) after SAH has occured ]
    The presence of vasospasm is assessed with the help of a transcranial doppler device. Vasospasm is diagnosed if the mean blood flow velocity in the middle cerebral artery is higher than 120 cm/s (centimeter/second)


Secondary Outcome Measures :
  1. 30-day survival [ Time Frame: 30 days after the incidence of SAH ]
  2. Glasgow Outcome Scale [ Time Frame: 30 days after the incidence of SAH ]
  3. Barthel Index of Activities of Daily Living [ Time Frame: 30 days after the incidence of SAH ]
  4. National Institutes of Health Stroke Scale [ Time Frame: 30 days after the incidence of SAH ]

Other Outcome Measures:
  1. Noradrenalin need [ Time Frame: 30 days after the incidence of SAH ]
    The overall noradrenalin need during hospital stay.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with subarachnoid hemorrhage
  • patients with Hunt-Hess grade I-III.

Exclusion Criteria:

  • patients with Hunt-Hess grade IV-V.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02064075


Locations
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Hungary
University of Debrecen Medical and Health Science Center Department of Anesthesiology and Intensive Care
Debrecen, Hungary, 4032
Sponsors and Collaborators
University of Debrecen
Investigators
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Principal Investigator: Csilla Molnár, Md, PhD University of Debrecen Medical and Health Science Center Department of Anesthesiology and Intensive Care 4032-Debrecen, Nagyerdei krt 98. Hungary Tel/fax: +36-52-255-347

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Responsible Party: Tamas Vegh, MD, assistant lecturer anesthesiologist and intensive care specialist, University of Debrecen
ClinicalTrials.gov Identifier: NCT02064075     History of Changes
Other Study ID Numbers: 6163-1/2013/EKU
DEOEC RKEB/IKEB:3799-2012 ( Other Identifier: University of Debrecen,RKEB/IKEB )
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: February 17, 2014
Last Verified: February 2014

Keywords provided by Tamas Vegh, MD, University of Debrecen:
Subarachnoid hemorrhage
vasospasm
Lactated Ringer's solution
Hydroxyethyl starch solution

Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Hemorrhage
Intracranial Hemorrhages
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Hydroxyethyl Starch Derivatives
Pharmaceutical Solutions
Plasma Substitutes
Blood Substitutes